Vaginal Progesterone in Twins With Short Cervix

Obstetrix Medical Group

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Premature Birth

Treatments: Procedure: fetal fibronectin swab.; Drug: Placebo gel; Drug: Vaginal Progesterone gel.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01812239

OBX0019

Details and patient eligibility

About

A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.

Full description

This is a placebo-controlled, double-blind, randomized clinical trial of asymptomatic women with twin pregnancy and a cervix length 10 mm to 25 mm discovered on a routine screening transvaginal sonogram between 20w0d to 24w0d gestational age. Women will be randomized in either the in-patient or out-patient setting (1:1) to a daily vaginal application of micronized progesterone cream(200 mg)vs. placebo to determine if daily vaginal progesterone administration reduces the risk of preterm birth prior to 34w0d of gestation.

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Gestational age between 20w0d and 24w0d
• Twin pregnancy, diamniotic-dichorionic, both twins living
• Cervical length 10 mm to 25 mm discovered by a screening transvaginal ultrasound exam

Exclusion criteria

• Mother less than 18 years of age

• Uterine contractions of 40 seconds duration or more, 10 or more per hour

• Rupture of fetal membranes (leakage of amniotic fluid one or both sacs)

• Ongoing vaginal bleeding

• Any condition likely to cause serious neonatal morbidity independent of gestational age, including:

  1. fetal malformation likely to require surgery
  2. fetal malformation involving vital organs
  3. fetal viral infection
  4. hydrops fetalis
  5. discordance in estimated fetal weight more than 10%
  6. velamentous insertion of umbilical cord of either twin
  7. placenta previa of either placenta

• Any contraindication to continuing the pregnancy

• Cervical cerclage in place or planned

• Any contraindication to vaginal micronized progesterone, including:

  1. Known sensitivity to progesterone or any of the other ingredients
  2. Liver dysfunction or disease
  3. Known or suspected malignancy of breast or genital organs
  4. Active thromboembolic disorder, or history of hormone-associated thromboembolic disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Vaginal Progesterone

Active Comparator group

Description:

Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy.

Treatment:

Drug: Vaginal Progesterone gel.

Procedure: fetal fibronectin swab.

Placebo

Placebo Comparator group

Description:

Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy.

Treatment:

Drug: Placebo gel

Procedure: fetal fibronectin swab.